To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics. Some waived tests have potential for serious health impacts if performed incorrectly. Errors can occur anywhere in the testing process, particularly when the manufacturer’s instructions are not followed and when testing personnel are not familiar with all aspects of the test system.
Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Content on this page was updated on 25-August-2022.
You may also access electronic Value Assignment Sheets (eVAS).
#Istat test answers verification
All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Use Value Assignment Sheets to locate the correct target values and ranges for your i-STAT test cartridge controls and calibration verification materials.
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